BS EN ISO 10993-18:2009

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Symbols and abbreviated terms
5 General principles
6 Characterization procedure
  6.1 General
  6.2 Step 1 - Qualitative information
  6.3 Step 2 - Material equivalence
  6.4 Step 3 - Quantitative information
  6.5 Step 4 - Quantitative risk assessment
  6.6 Step 5 - Estimated clinical exposure to chemicals
      present
7 Chemical characterization parameters and methods
  7.1 General
  7.2 Polymers
  7.3 Metals and alloys
  7.4 Ceramics
  7.5 Natural macromolecules
8 Reporting of data obtained
Annex A (normative) - Flowchart summarizing the stepwise
        generation of chemical characterization data for
        use in toxicological risk assessment
Annex B (informative) - Information sources for chemical
        characterization
Annex C (informative) - Principles for judging toxicological
        equivalency
Bibliography
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC on Medical Devices
Annex ZB (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 90/385/EEC on Active Implantable
         Medical Devices

Specifies a framework for the identification of a material and the identification and quantification of its chemical constituents.